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Recall Observatory FDA recall evidence

Device product

Curity All Purpose Sponges, Non-woven, 4 Ply, 4" x 4" (10.2 cm x 10.2 cm) Product Code: 8044 - Product Usage: Ideal for applying ointments, prepping, wiping needles, cleaning slides and more Rayon/polyester blend construction Highly absorbent.

Z-0957-2019

December 27, 2018

Class II

Product summary

Firm
Cardinal Health 200, LLC
Event
Event 82008
Status
Terminated
Classification
Class II
Quantity
10,400 units (13 cases, 800 units/case)
Official record key
device-enforcement:Z-0957-2019

Official wording

Reason: Curity All Purpose Sponges were not sterilized and distributed

Code information: Lot Number: 18E190262 Expiration Date: 05/2023

Distribution pattern: Worldwide distribution - US Nationwide and countries of Canada, Colombia.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Curity All Purpose Sponges were not sterilized and distributed